Olmesartan Tablet, film coated 40mg

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

OLMESARTAN MEDOXOMIL

Disponible desde:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Código ATC:

C09CA08

Designación común internacional (DCI):

OLMESARTAN MEDOXOMIL 40 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

OLMESARTAN MEDOXOMIL 40 mg

tipo de receta:

POM

Área terapéutica:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Estado de Autorización:

Authorised

Fecha de autorización:

2014-08-14

Información para el usuario

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN 10 MG FILM-COATED TABLETS
OLMESARTAN 20 MG FILM-COATED TABLETS
OLMESARTAN 40 MG FILM-COATED TABLETS
olmesartan medoxomil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Olmesartan
is and what it is used for
2.
What you need to know before you take Olmesartan
3.
How to take Olmesartan
4.
Possible side effects
5.
How to store Olmesartan
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN IS AND WHAT IT IS USED FOR
Olmesartan
belongs to a group of medicines called angiotensin-II receptor
antagonists. They lower
blood pressure by relaxing the blood vessels.
Olmesartan
is used for the treatment of high blood pressure (also known as
“hypertension”) in
adults and in children and adolescents aged 6 to less than 18 years.
High blood pressure can damage
blood vessels in organs such as the heart, kidneys, brain and eyes. In
some cases this may lead to a
heart attack, heart or kidney failure, stroke or blindness. Usually
high blood pressure has no
symptoms. It is important to have your blood pressure checked to
prevent damage occurring.
High blood pressure can be controlled with medicines such as
Olmesartan
tablets. Your doctor has
probably also recommended that you make some changes in your lifestyle
to help lower your blood
pressure (for example losing weight, giving up smoking, reducing the
amount of alcohol you drink
and reducing the amount of salt in your diet). Your doctor may also
have urged you to take regular
exerci

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olmesartan 10 mg film-coated tablets
Olmesartan 20 mg film-coated tablets
Olmesartan 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Olmesartan_
_10 mg film-coated tablets _
Each film-coated tablet contains 10 mg of olmesartan medoxomil
Excipient with known effect: Each film-coated tablet contains 65.250
mg lactose monohydrate.
_Olmesartan_
_20 mg film-coated tablets _
Each film-coated tablet contains 20 mg of olmesartan medoxomil
Excipient with known effect: Each film-coated tablet contains 130.500
mg lactose monohydrate.
_Olmesartan_
_40 mg film-coated tablets _
Each film-coated tablet contains 40 mg of olmesartan medoxomil
Excipient with known effect: Each film-coated tablet contains 261.000
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Olmesartan 10mg film-coated tablets:_
Orange coloured, round shaped, biconvex, film-coated tablets debossed
with ‘K’ on one side and
‘17’ on the other side. The size is 6.7 mm.
_Olmesartan 20mg film-coated tablets_
White coloured, round shaped, biconvex, film-coated tablets debossed
with ‘K’ on one side and ‘18’
on the other side. The size is 8.6 mm.
_Olmesartan 40mg film-coated tablets_
White coloured, oval shaped, biconvex film-coated tablets debossed
with ‘K’ on one side and ‘19’
on the other side. The size is 15.3 mm x 7.3 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of essential hypertension in adults.
•
Treatment of hypertension in children and adolescents from 6 to less
than 18 years of age.
Page
2
of
16
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The recommended starting dose of olmesartan medoxomil is 10 mg once
daily. In patients whose
blood pressure is not adequately controlled at this dose, the dose of
olmesartan medoxomil may be
increased to 20 mg once daily as the optimal dose. If additional blood
pressure reduction is required,
olme